FDA device listing
Boley Gauge,Boon Bracket Positioning Gauge,Boon Gauge,Bracket Gauge,CASTROVIEJO CALIPER,Crown Gauge With Scale,Endo Ring…
FDA device listing 1565110378 · Zain's Medical Image
Key facts
| Proprietary names | Boley Gauge,Boon Bracket Positioning Gauge,Boon Gauge,Bracket Gauge,CASTROVIEJO CALIPER,Crown Gauge With Scale,Endo Ring Ruler,Finger Ruler,Stainless Steel Ruler,Stainless Steel Ruler 6 |
|---|---|
| Owner/operator | Zain's Medical Image |
| Owner/operator number | 9047917 |
| Product codes | FTY |
| Device names | FTY - Tape, Measuring, Rulers And Calipers |
| Device class | Class I |
| Classification regulations (21 CFR) | 878.4800 |
| Review panels | General & Plastic Surgery |
| Registered establishments | ZAIN'S MEDICAL IMAGE |
| Establishment registrations | 3003877407 |
| FEI numbers | 3003877407 |
| Establishment operations | Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None listed Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database